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ISRCTN
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ISRCTN46112469
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ClinicalTrials.gov identifier
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Public title
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A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a "dose banding" principle
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0436118084
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Study hypothesis
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The main aim of the project is to evaluate the concept of dose-binding chemotherapy drugs as a means of improving pharmacy efficiency and reducing patients waiting times. This study aims to compare the plasma profiles of the drug 5FU in breast cancer patients receiving dose-banded and the usual, individually prepared, doses as part of their normal FEC chemotherapy regimen.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer: Breast
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Participants - inclusion criteria
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All study participants will be women with breast cancer who are receiving adjuvant therapy.
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Participants - exclusion criteria
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Patients on reduced doses of FEC chemotherapy, with known liver metastases, who have received chemotherapy for previous malignancies.
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Anticipated start date
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01/03/2002
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Anticipated end date
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01/03/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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26
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Interventions
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Randomised controlled trial
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Primary outcome measure(s)
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The comparative plasma concentration profiles (Cmax, AUC) in patients receiving dose-banded and individually prepared doses of 5 Fluorouracil.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leeds Teaching Hospitals NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Ms
V A
Walker
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Address
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Department of Medical Oncology
Level 4
Gledhow Wing
St James's University Hospital
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44 (0)113 243 3144
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Fax
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+44 (0)113 242 6496
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Email
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r&d@leedsth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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14/12/2006
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Date ISRCTN assigned
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30/09/2005
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